INTRODUCTION
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Indications for Use
The RScribe electrocardiograph is a non-invasive prescription device.
The device is indicated for use to acquire, analyze, display, transmit and print electrocardiograms.
The device is indicated for use to provide interpretation of the data for consideration by a physician.
The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting
on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of ECG offered by the device are only significant when used in conjunction with a
physician over-read as well as consideration of all other relevant patient data.
The device is indicated for use on adult and pediatric populations.
The device is not intended to be used as a vital signs physiological monitor.
The device is not designed for out of hospital transport.
The device is not designed for use in highly invasive environments, such as an operating theatre.
System Description
RScribe is a multi-lead, diagnostic, computer-based resting electrocardiograph capable of acquiring, viewing,
transmitting, printing, and storing ECG data.
RScribe models ordered with the VERITAS™ resting ECG interpretation algorithm option are capable of specific
age and gender interpretation criteria. The VERITAS algorithm provides an over-reading physician with a silent
second opinion through diagnostic statements displayed on the ECG report. For additional information on the
VERITAS algorithm, please refer to the
Physician’s Guide to VERITAS with Adult and Pediatric Resting ECG
Interpretation
(see Accessories).
RScribe can be configured with bidirectional connectivity and DICOM
®
protocol support.
The RScribe application is integrated with a patient and exam management system that handles the scheduling of
exams, database storage and maintenance, exam and patient search, printing, communication with external systems
and dispatches the modality dependent acquisition and review functions. RScribe can be configured for data
distribution. When so configured, the database resides on a server supporting a number of networked client
workstations.
The RScribe Review software offers authorized users with the ability to schedule new exams when not linked to an
external scheduling system, view reports, enter conclusions, and generate printed or electronic reports for completed
exams.
The RScribe server, workstations, and review stations can be set up as Citrix
®
Application Servers for remote access
from client computers with Citrix XenApp™ installed.
The RScribe supports print formats that include:
Standard or Cabrera,
3+1,
3+3,
12,
6+6 channel in automatic mode;
Single channel on one page (60 min of acquired ECG for rhythm strip (Full Disclosure) printing.
The RScribe packing list includes:
Acquisition module with lead wire set and accessory starter kit
Software CD
Physician’s Guide to VERITAS and User Manual PDFs on CD
